FDA 510(k) Applications Received During September, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K152709 09/21/2015 HI-TORQUE BALANCE ABBOTT VASCULAR JOCHEN REICH
K152573 09/09/2015 4Sight ACCUTOME, INC. ADAM PICKHOLTZ
K152721 09/21/2015 Cytal Wound Matrix ACELL, INC THOMAS GILBERT
K152547 09/08/2015 DNAP Electrode Ad-Tech Medical Instrument Corporation Lisa Theama
K152769 09/25/2015 FREMAP ELECTRODE AD-TECH MEDICAL INSTRUMENT CORPORATION LISA THEAMA
K152776 09/25/2015 Glocyte Automated Cell Counter System Advanced Instruments, Inc. Robert Mello
K152724 09/22/2015 EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES ADVANCED VISION TECHNOLOGIES KEITH PARKER
K152639 09/15/2015 DR 600 AGFA HEALTHCARE N.V. Koren Vervoort
K152576 09/09/2015 Anker II Dental Implant System Alliance Global Technology Co., Ltd. YAYUAN CHANG
K152845 09/29/2015 Allied Biocompat Abutment for Nobel Replace Interface ALLIED DENTAL SOLUTIONS Peter Zhou
K152509 09/02/2015 CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) ALTATEC GMBH COLLEEN BOSWELL
K152819 09/28/2015 Amecath Peripheral inserted Central Venous Catheter Sets AMECO MEDICAL INDUSTRIES Samy Hamboly
K152555 09/08/2015 Dental Implant System AriaBio International Inc Hagai Jacobsen
K152527 09/03/2015 Integra DigiFuse Cannulated Intramedullary Fusion System Ascension Orthopedics Jayana Kenana
K152740 09/23/2015 Radifocus Glidewire ASHITAKA FACTORY OF TERUMO CORP. PHEBE VARGHESE
K152768 09/24/2015 Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip ASSURE TECH. CO., LTD. ERIC LIN
K152512 09/02/2015 Half Dome Posterior Lumbar Interbody System Astura Medical Thomas Astura
K152732 09/22/2015 AOS Small Fragment Plating System AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) Mark Steinhauer
K152618 09/14/2015 PANTHER Cutter Stapler B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD LINA YUN
K152765 09/24/2015 VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM B.BRAUN INTERVENTIONAL SYSTEMS INC. PETER FLOSDORF
K152510 09/02/2015 UltraCor Twirl Breast Tissue Marker BARD PERIPHERAL VASCULAR, INC. KRISTEN DEJEU
K152675 09/18/2015 EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER BAXTER HEALTHCARE JOHN LAMELA
K152852 09/29/2015 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) BAYER HEALTHCARE, LLC William R Walsh
K152870 09/30/2015 BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit BECTON DICKINSON AND CO. GREGORY P. PAYNE
K152874 09/30/2015 BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit BECTON DICKINSON, AND CO. GREG PAYNE
K152516 09/03/2015 BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks BECTON, DICKINSON AND COMPANY LAURA STEWART
K152563 09/09/2015 Pulse Oximeter (MD300M/MD300K2) BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K152571 09/09/2015 Stivax BIEGLER GMBH FRIEDRICH NETAUSCHEK
K152679 09/18/2015 Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak BIO-RAD LABORATORIES ELIZABETH PLATT
K152589 09/10/2015 Bio2 CLM BG Bioactive Scaffold Bio2 Technologies, Inc Janet Krevolin
K152579 09/10/2015 FilmArray Respiratory Panel EZ (RP EZ) BIOFIRE DIAGNOSTICS, LLC KRISTEN J. KANACK
K152754 09/24/2015 COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K152868 09/30/2015 ExpressBraid Graft Manipulation BIOMET MANUFACTURING CORP. ADAM CARGILL
K152622 09/14/2015 Alta ACDF System BIOMET SPINE ALEXANDRA BECK
K152621 09/14/2015 OSS/Arcos IM Total Femur Rod BIOMET, INC. BRYAN MCMAHON
K152889 09/30/2015 SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS BIORENEW LABS, LLC JON DAVID
K152574 09/09/2015 Navio BLUE BELT TECHNOLOGIES, INC RICHARD G. CONFER
K152764 09/24/2015 EXACTECH GPS BLUE ORTHO ANTHONY BOYER
K152607 09/11/2015 Express SD Biliary Monorail Premounted Stent System BOSTON SCIENTIFIC ANNA DERANEY
K152853 09/29/2015 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary BOSTON SCIENTIFIC CORP. CARAH KUCHARSKI
K152572 09/09/2015 AXIOS Stent and Delivery System BOSTON SCIENTIFIC CORPORATION ASHLEY SANTOS
K152693 09/21/2015 CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels BOSTON SCIENTIFIC CORPORATION MAYLIN TRUESDELL
K152605 09/11/2015 Impulse Angiographic Catheter, Expo Angiographic Catheter BOSTON SCIENTIFIC CORPORATION MAC MCKEEN
K152842 09/29/2015 WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL BOSTON SCIENTIFIC CORPORATION CARAH KUCHARSKI
K152777 09/25/2015 Bovie Disposable Bipolar Ablator BOVIE MEDICAL CORPORATION BRIAN KUNST
K152570 09/09/2015 Bovie J-Plasma Precise 360 Handpiece BOVIE MEDICAL CORPORATION BRIAN KUNST
K152731 09/22/2015 XP1100 RF BTL INDUSTRIES, INC JAN ZARSKY
K152613 09/14/2015 True Flow Valvuloplasty Perfusion Catheter C. R. BARD, INC. AARON CONOVALOFF
K152736 09/23/2015 SKIN CARE C.I.S LTD ILAN SHARON
K152554 09/08/2015 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc. Kerrie Hamblin
K152568 09/09/2015 C-VBR CARDINAL SPINE, LLC NATASHA LONNON
K152503 09/02/2015 ImagenSPECT CARDIOVASCULAR IMAGING TECHNOLOGIES JAMES CASE
K152694 09/21/2015 Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems Inc. Kim Wallner
K152593 09/10/2015 LATEX EXAMINATION GLOVE POWDER FREE Careplus (M) SDN BHD LIM KWEE SHYAN
K152825 09/29/2015 Catalyst CSR Shoulder System CATALYST ORTHOSCIENCE LLC STEPHEN HERRINGTON
K152826 09/29/2015 NoCord CENTRIX, INC. GREG MOREAU
K152614 09/14/2015 Xpert Carba-R CEPHEID SCOTT A. CAMPBELL
K152515 09/02/2015 TOMCAT Cervical Spinal System CHOICE SPINE, LP Kim Finch
K152600 09/11/2015 Collagen Dental Wound Dressings COLLAGEN MATRIX, INC. GLORIA ZUCLICH
K152834 09/29/2015 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 COLONPLUS EQUIPMENTS & SPECULUMS, S.L. Jorge Echevarria
K152704 09/21/2015 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System CONFORMIS, INC AMITA SHAH
K152860 09/30/2015 HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL CONMED CORPORATION LISA ANDERSON
K152863 09/30/2015 Portable ECG Monitor CONTEC MEDICAL SYSTEMS CO., LTD XUEYONG LI
K152524 09/03/2015 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set COOK INCORPORATED ERUM B. NASIR
K152590 09/10/2015 ACCU NEWS Drug Screening Test Card/Urine Cup CORETESTS, INC ERIC SUN
K152893 09/30/2015 Corin Optimized Positioning System (OPS) CORIN USA Kathy Trier
K152565 09/09/2015 Auto Suture Locking Trocar COVIDIEN MICHAEL KOCZOCIK
K152586 09/10/2015 Beacon Fine Needle Fiducial System Covidien LLC RACHEL SILVA
K152794 09/28/2015 Cytosponge Cell Collection Device Covidien LLC Clare Santulli
K152668 09/17/2015 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K152878 09/30/2015 SUNTEC Mechanical Wheelchair, model ST-WL-1000 DANYANG SUNTEC AUTO PARTS CO., LTD. JEN KE-MIN
K152767 09/24/2015 OTC12D AUTO RADIOGRAPHIC SYSTEM DEL MEDICAL, INC. JOHN HARTZELL
K152766 09/24/2015 CharmFlex DENTKIST, INC SHIN HEANG LEE
K152861 09/30/2015 Aquasil Ultra + Smart Wetting Impression Material DENTPLY INTERNATIONAL INC. HELEN LEWIS
K152587 09/10/2015 DermaScalp Laser Cap DERMASCALP LLC JOHN CARULLO
K152810 09/28/2015 DeVilbiss DV6WM Wireless Modem DeVilbiss Healthcare, LLC Betty Miller
K152645 09/16/2015 Dictum Health DICTUM HEALTH, INC PAUL LANDESMAN
K152859 09/30/2015 Portable X-ray System (Model: MINIX-V / MINIX-S) DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) YOUNGBAE KWON
K152667 09/17/2015 ATOVEN-Reusable Laser Fiber DIOTECH CO LEE KYUNG YONG
K152556 09/08/2015 Oragene Dx DNA Genotek Inc Dan Fullerton
K152508 09/02/2015 Ageless Health Medical Digital Thermometer DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD VICTOR WAN
K152591 09/10/2015 Medilas H RFID Laser Fibers Dornier MedTech America, Inc. John Hoffer
K152507 09/02/2015 Dr. Wolff Vagisan Moisturising Cream DR. AUGUST WOLFF GMBH & CO. KG ARZEIMITTEL THOMAS FLOETOTTO
K152522 09/03/2015 ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes ECOLAB, INC. Jennifer Willner
K152552 09/08/2015 Patient Monitor EDAN INSTRUMENTS, INC. QUEENA CHEN
K152633 09/15/2015 Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe EDWARDS LIFESCIENCES, LLC DEANA BOUSHELL
K152762 09/24/2015 Fogarty Occlusion Catheter EDWARDS LIFESCIENCES, LLC. Naren Murugan
K152713 09/21/2015 8MP Color LCD Monitor, RadiForce RX850, RX850-AR EIZO CORPORATION HIROAKI HASHIMOTO
K152558 09/09/2015 Leksell Stereotactic System, Injection/ Aspiration Needle Kit ELEKTA INSTRUMENT AB EMMA WIDMARK
K152580 09/10/2015 rescuenet ENDOCHOICE, INC. DANIEL HOEFER
K152702 09/21/2015 ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) ENT BIOTECH SOLUTIONS LAURA YAMADA
K152788 09/25/2015 EOS System EOS IMAGING MATHIAS BREUIL
K152691 09/21/2015 EDS Universal Cement ESSENTIAL DENTAL SYSTEMS, INC JEFFREY WAN
K152490 09/01/2015 DERMABOND PRINEO Skin Closure System ETHICON, INC. DONNA MARSHALL
K152553 09/08/2015 CueSee Hypoxic EUROTROL B.V. Paul Kooijmans
K152746 09/23/2015 Ez3D Plus EWOO SOFT CO., LTD. YOUNG SEOK KIM
K152710 09/21/2015 HammerFiX Device EXTREMITY MEDICAL, LLC BRIAN SMEKAL
K152677 09/18/2015 geko T-2 Neuromuscular Stimulator FIRSTKIND LIMITED NEIL BUCKLEY
K152737 09/23/2015 Lite Touch FOCUS MEDICAL LLC JOHN B LEE
K152529 09/03/2015 NaturaLase CO2 Laser System FOCUS MEDICAL, LLC JOHN B LEE
K152640 09/15/2015 Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) FUDAKANG INDUSTRIES CO., LTD BOB YU
K152676 09/18/2015 FD TENS 2090, FD TENS 2095 FUJI DYNAMICS LTD MAN CHUNG MAN
K152722 09/22/2015 neoV980 & neoV1470 Diode Lasers G.N.S NEO LASER LTD. GIL SHAPIRA
K152557 09/08/2015 Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters G21 s.r.l. Maurizio Foroni
K152652 09/16/2015 PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement GAIA DENTAL PRODUCTS, INC. WEITAO JIA
K152528 09/03/2015 Attachable Cath Lab Hemostasis Valve GALT MEDICAL CORP. DAVID DERRICK
K152567 09/09/2015 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System GE Healthcare Ayesha Pergadia
K152584 09/10/2015 Stroke VCAR GE MEDICAL SYSTEMS SCS Peter Uhlir
K152758 09/24/2015 Venue 50 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K152612 09/14/2015 eSensor Warfarin Sensitivity Saliva Test GENMARK DIAGNOSTICS, INCORPORATED ALAN MADERAZO
K152701 09/21/2015 Matrix Mini ECG Monitor GLOBAL INSTRUMENTATION, LLC CRAIG SELLERS
K152739 09/23/2015 Electronic Thermometer GUANGDONG BIOLIGHT MEDITECH CO., LTD JING LIANG
K152495 09/01/2015 Wondfo Propoxyphene Urine Test Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K152744 09/23/2015 DIEGO ELITE DRILL GYRUS ACMI, INC DOLAN MILLS
K152531 09/03/2015 InstaClear Lens Cleaner GYRUS ACMI, INC. DOLAN MILLS
K152715 09/21/2015 HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR HAINING MEDICAL PRODUCTS CO., LTD ZHANG LIANG
K152838 09/29/2015 HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 HARDY DIAGNOSTICS WENDY HADLEY
K152846 09/29/2015 HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 HARDY DIAGNOSTICS WENDY HADLEY
K152733 09/22/2015 FFRct HEARTFLOW, INC. WINDI HARY
K152533 09/03/2015 Xonrid Gel Helsinn Healthcare SA Valentina Tombolini Bossi
K152661 09/17/2015 HICAT Air HICAT GmbH Frederik Kunze
K152592 09/10/2015 PROBEAT-V Hitachi, Ltd.,Health Care Company NAOYA NISHIMURA
K152723 09/22/2015 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices HOLOGIC, INC CATHERINE EATON
K152818 09/28/2015 Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves Ideal Plastic Co., Ltd. Lily Li
K152491 09/01/2015 MoMe Software Platform INFOBIONIC, INC. MATTHEW KING
K152520 09/03/2015 Magicore System INNOBIOSURG CO., LTD BO-REUM YOO
K152505 09/02/2015 C2 NerveMonitor System INOMED MEDIZINTECHNIK GMBH SASCHKA BUSCH
K152875 09/30/2015 QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K152635 09/15/2015 QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls INOVA DIAGNOSTICS, INC. Gabriella Lakos
K152596 09/10/2015 Intact« Gen2 System INTACT MEDICAL CORPORATION JOHN VACHA
K152892 09/30/2015 da Vinci Xi Surgical System INTUITIVE SURGICAL Crystal Ong
K152663 09/17/2015 Bladeless Optical Obturators INTUITIVE SURGICAL, INC. VISHAL KANANI
K152578 09/10/2015 da Vinci Surgical System, Model IS4000 INTUITIVE SURGICAL, INC. Brandon Hansen
K152493 09/01/2015 POGO Automatic Blood Glucose Monitoring System INTUITY MEDICAL, INC Robb Hesley
K152536 09/04/2015 MyOn HC Manual Wheelchair INVACARE CORPORATION Elijah N. Wreh
K152727 09/22/2015 ISEN-Goggles ISEN TECH & TRADING COMPANY, LTD. MARTIN LIU
K152538 09/04/2015 JRP Wound Spreader J.R. PARKER, LLC J RICHARD PARKER
K152606 09/11/2015 Jeesung Safety Syringe and Single Use Needles JEESUNG MEDICAL CO LTD Choi Yong Hyun
K152705 09/21/2015 Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color Jiayuan Medical Products Co., Ltd Wang Lihong
K152872 09/30/2015 K2M Fenestrated Tap System K2M NANCY GIEZEN
K152887 09/30/2015 Crosperio RX PTA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K152873 09/30/2015 Crosstella RX Balloon Dilatation Catheter KANEKA CORPORATION TOSHIHIKO MOTOMINE
K152583 09/10/2015 KARL STORZ Endoscopic ICG Imaging System KARL STORZ ENDOSCOPY-AMERICA, INC. Mike Samuels
K152748 09/23/2015 Braun Thermoscan PRO 6000 Ear Thermometer KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC) RAJ KASBEKAR
K152644 09/16/2015 KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 KEELER LIMITED IRINA PROUTSKI
K152577 09/09/2015 ULTRASOUND SYSTEM SONIMAGE HS 1 KONICA MINOLTA, INC. SHIGEYUKI KOJIMA
K152856 09/29/2015 Helios III LASEROPTEK CO. LTD. HONG CHU
K152642 09/15/2015 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode LCCS PRODUCTS LIMITED JAMES LIN
K152833 09/29/2015 Pruitt F3-S Polyurethane Carotid Shunt LEMAITRE VASCULAR, INC. ANNA KASSERIS
K152581 09/10/2015 LifeGlobal Micro Tips LifeGlobal Group, LLC Michael D. Cecchi
K152843 09/29/2015 Liger Medical HTU-110 LIGER MEDICAL, LLC STEVE SMITH
K152688 09/18/2015 LightLas Multi-Wavelength Medical Laser System LIGHTMED CORPORATION Mollie Li
K152672 09/18/2015 Cajun Commando 4x4 LIL CRITTER, LLC BRENDA BRANT
K152848 09/29/2015 AUTOLAP SYSTEM M.S.T Medical Surgery Technologies LTD Tami Harel
K152659 09/17/2015 V10 MEDIANA CO., LTD KIM MIN HYE
K152585 09/10/2015 Resmon PRO FULL MEDICAL GRAPHICS CORP. JIM PURDIE
K152519 09/03/2015 MTR550 (Tentative) Antimicrobial Silver Wound Gel MEDICAL TECHNOLOGY RESEARCH INC. Bhalchandra M. Karandikar
K152550 09/08/2015 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM MEDICALGORITHMICS S.A. MAREK J. DZIUBINSKI
K152564 09/09/2015 Gemini Sterilization Wrap MEDLINE INDUSTRIES, INC. Jennifer Mason
K152670 09/17/2015 DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables Medos International SARL Elena Jugo
K152703 09/21/2015 PlasmaBlade TnA Tonsil and Adenoid Dissection Device MEDTRONIC ADVANCED ENERGY LYDIA SAKAKEENY
K152700 09/21/2015 StrataMR Valves and Shunts MEDTRONIC NEUROSURGERY Micah Schloss
K152623 09/14/2015 ATLANTIS Anterior Cervical Plate System MEDTRONIC SOFAMOR DANEK USA, INC LAVEEDA LEFLORE
K152604 09/11/2015 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set Medtronic Sofamor Danek USA, Incorporated Pamela Edwards
K152496 09/01/2015 CPX 4 Breast Tissue Expander MENTOR WORLDWIDE LLC Manchi Cheung
K152864 09/30/2015 Merge Hemo MERGE HEALTHCARE INCORPORATED MIKE DIEDRICK
K152800 09/28/2015 illumigene Mycoplasma DNA Amplification Assay MERIDIAN BIOSCIENCE, INC. Stefanie Johns
K152783 09/25/2015 Merit 20 mL Syringe Merit Medical Systems, Inc. CORY MARSH
K152627 09/15/2015 IFS Fixation Scaffold System METRIC MEDICAL DEVICES, INC. W.Casey Fox
K152802 09/28/2015 Grasping Forceps MICRO-TECH (NANJING) CO., LTD. BECKY LI
K152770 09/25/2015 ProBP 2400 Digital Blood Pressure Device MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K152743 09/23/2015 M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) MICROLINE SURGICAL, INC. ANU GAUR
K152745 09/23/2015 ReNew Sterilization Trays(Catalog #3708 and #3709) MICROLINE SURGICAL, INC. ANU GAUR
K152625 09/15/2015 MMS Guide Catheter MicroMedical Solutions, Inc. Gregory Mathison
K152631 09/15/2015 MPO Total Knee Systems MR Labeling MICROPORT ORTHOPEDICS, INC. USMAN RASHID
K152707 09/21/2015 Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color MINGHAO MEDICAL PRODUCTS CO.,LTD. PANG CUIRU
K152867 09/30/2015 MHI-TM2000 Linear Accelerator System, VERO, Imavis MITSUBISHI HEAVY INDUSTRIES, LTD. KATSUHISA TOYAMA
K152741 09/23/2015 Mepiseal Soft Silicone Sealant MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K152749 09/23/2015 moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager Moor Instruments Ltd Stewart Lillington
K152626 09/15/2015 H3+ Holter Recorder MORTARA INSTRUMENT, INC Margaret Mucha
K152643 09/15/2015 EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana NANTONG EGENS BIOTECH CO., LTD. Yan Cao
K152598 09/11/2015 Endo Keeper NELIS SEO OU NAM
K152857 09/30/2015 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps NEOMED, INC. TONY LAIR
K152560 09/09/2015 Bard Snare Retrieval Kit NEOMETRICS, INC DAVE LIEBL
K152501 09/01/2015 Spinal Jaxx Interbody Fusion Device NEUROPRO SPINAL JAXX, INC. BENJAMIN J. REMINGTON
K152664 09/17/2015 TAV System New Aera, Inc. ERIC JOHANSSON
K152548 09/08/2015 AXI+LINE Proximal Bunion Correction System NEXTREMITY SOLUTIONS, Inc. Ryan Schlotterback
K152603 09/11/2015 Green Laser Photocoagulator GYC-500 NIDEK CO., LTD. YONEJI MIZUNO
K152729 09/22/2015 MICROPERIMETER MP-3 NIDEK CO., LTD. YONEJI MIZUNO
K152836 09/29/2015 TREFOIL System NOBEL BIOCARE AB CHARLEMAGNE CHUA
K152665 09/17/2015 PolarCath Peripheral Dilatation System NUCYRO VASCULAR, LLC MIKE FOURKAS
K152890 09/30/2015 SACCADOMETER PLUS, SACCADOMETER ADVANCED OBER CONSULTING SP. Z.O.O. JAN KRZYSZTOF OBER
K152809 09/28/2015 Giraffe Incubator Carestation CS1 OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. KENNY BELLO
K152814 09/28/2015 Giraffe OmniBed Carestation CS1 Ohmeda Medical, a Division of Datex-Ohmeda,Inc. A GE Company Kenny M Bello
K152599 09/11/2015 PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System OK BIOTECH CO., LTD. KE-MIN JEN
K152602 09/11/2015 Olea Sphere V3.0 OLEA MEDICAL CAROLINE LENE
K152498 09/01/2015 SoloPath Re-Collapsible Access System ONSET MEDICAL CORPORATION Monika McDole-Russell
K152779 09/25/2015 Avex CX2 Opal Orthodontics by Ultradent Products Marie Hess
K152813 09/28/2015 FS-500DDR Medical Radiographic X-Ray System ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. JU PENG
K152830 09/29/2015 K3 OSSTEM IMPLANT CO.,LTD. BYEUNGHUN KIM
K152820 09/28/2015 Ponto Bone Anchored Hearing System OTICON MEDICAL AB CAROLINA ANKER WESSLING
K152489 09/01/2015 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray PANORAMIC CORP. Doug Pack
K152711 09/21/2015 Parcus GFS Naked PARCUS MEDICAL, LLC PAUL VAGTS
K152636 09/15/2015 Laser Dock PATIENT POCKET, LLC ALLEN D SEFTEL
K152699 09/21/2015 Apollo System PENUMBRA, INC. MARY ROSE
K152840 09/29/2015 Lantern Delivery Microcatheter PENUMBRA, INC. CHARLES DENAULT
K152541 09/04/2015 Penumbra System ACE 64 and ACE 68 Reperfusion Catheters PENUMBRA, INC. MICHAELA MAHL
K152690 09/21/2015 DISPOSABLE THERMOMETER PROBE SHEATHS PINGHU SAMA MEDICAL PACKING CO., LTD. MA JIANZHONG
K152793 09/28/2015 Unison-C Anterior Cervical Fixation System PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC. EMILY ROBERGE
K152669 09/17/2015 PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD DERYA DIKICI
K152684 09/18/2015 Nerve Capping Device POLYGANICS INNOVATIONS BV BETTY IJMKER
K152884 09/30/2015 DermaTherapy Bed Linens PRECISION FABRICS GROUP, INC. Terry Montgomery
K152561 09/09/2015 Communicator Surgical Facemask with Clear Window Prestige Ameritech, Ltd Rex Reese
K152511 09/02/2015 Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula PROSURG, INC ASHVIN DESAI
K152619 09/14/2015 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) PROSURG, INC. ASHVIN DESAI
K152716 09/21/2015 EV Insite System PSP Corporation Kenji Ishida
K152695 09/21/2015 8 CH Knee SPEEDER QUALITY ELECTRODYNAMICS, LLC. KATHLEEN ARAS
K152714 09/21/2015 Quanta Forte QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K152847 09/29/2015 DIVA ZSP5812CMI with QUBYX PerfectLum bundle QUBYX LTD. MARC LEPPLA
K152882 09/30/2015 Propeller System RECIPROCAL LABS DAVID HUBANKS
K152624 09/14/2015 XSTAT 30, 3-PACK, XSTAT 30, 1-PACK REVMEDX, INC. AMY K. POINTER
K152795 09/28/2015 RiverLon (Nylon) Suture RIVERPOINT MEDICAL Edwin Anderson
K152542 09/04/2015 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs RIVERSTONE RESOURCES SDN BHD SURESH KUMAR
K152526 09/03/2015 Elecsys Progesterone III CalSet ROCHE DIAGNOSTICS Patty Bates
K152827 09/29/2015 Weely Manual Wheelchair Rupiani Jean-Marie Mangenot
K152513 09/02/2015 8X-10-XXXX Camera System Santa Barbara Imaging Systems James Candy
K152687 09/18/2015 Arm-Type Fully Automatic Digital Blood Pressure Monitor SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Ren Yunhua
K152824 09/29/2015 MEDT PEN NEEDLE SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD. LIN YANYAN
K152517 09/03/2015 Nitrile Examination Gloves, Powder Free, (White) SHANDONG FEIYANG PROFESSIONAL GLOVES COMPANY LIMITED KEN LU
K152781 09/25/2015 Adena-Zina System SHANGHAI SANYOU MEDICAL CO, LTD DAVID FAN
K152815 09/28/2015 Mailuokang Self-adhesive Electrode SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD. HU PANDENG
K152545 09/08/2015 DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K152543 09/04/2015 M9/M9CV/M9T Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Wu Zicui
K152763 09/24/2015 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Zhai Pei
K152544 09/04/2015 Agem Ag Mesh Dressing with Silver SHENZHEN YUANXING NANO-PHARMA CO., LTD LIU LONGQING
K152879 09/30/2015 Sure-Fine Insulin Syringes SHINA MED CORPORATION SUNG-SOON PARK
K152877 09/30/2015 SureFine Pen Needle SHINA MED CORPORATION SUNG-SOON PARK
K152681 09/18/2015 iFuse Implant System(R) SI-BONE, INC. ROXANNE DUBOIS
K152880 09/30/2015 Biograph Horizon PET/CT SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K152757 09/24/2015 SIGN Hip Construct (SHC) SIGN FRACTURE CARE INTERNATIONAL Rob Teeter
K152831 09/29/2015 Spot Skan SKANRAY TECHNOLOGIES PRIVATE LIMITED MAHADEVAN J
K152657 09/16/2015 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens SMART PERFORMER CORP. LTD. Jeffersion Shen
K152686 09/18/2015 CONQUEST FN Smith & Nephew Bradley Heil
K152726 09/22/2015 JOURNEY II XR Knee System SMITH & NEPHEW, INC. BRAD SHEALS
K152566 09/09/2015 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor SMITH & NEPHEW, INC. KATHERINE MARCACCIO
K152660 09/17/2015 HYPNOSPAD Somnics Inc. TSUNG-MIN HSIEH
K152854 09/29/2015 S50 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152881 09/30/2015 SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM SPACELABS HEALTHCARE LTD. AL VAN HOUDT
K152662 09/17/2015 S-Wire Spinal Resources Inc Bernard Bedor
K152539 09/04/2015 SpineView X-Pac Expandable Lumbar Cage System SPINE VIEW, INC. Mbithi Muthini
K152620 09/14/2015 Spine Wave Gen II Expandable Interbody System SPINE WAVE, INC. Gail Yaeker-Daunis
K152747 09/23/2015 DSG Threaded Drill System SPINEGUARD, S.A. STEPHANE BETTE
K152784 09/25/2015 Pacel Bipolar Pacing Catheters ST. JUDE MEDICAL PARITA MEHTA
K152597 09/11/2015 ProteXsure Safety Capsule System StarCap Medical LLC ( DBA Prism Medical & Design) Les Capella
K152801 09/28/2015 ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT STATCORP MEDICAL WAYNE EMMERT
K152630 09/15/2015 VERIFY STEAM Integrating Indicator STERIS CORPORATION BILL BRODBECK
K152651 09/16/2015 AccuLIF TL and PL Cage STRYKER CORPORATION AAKASH JAIN
K152641 09/15/2015 Pi Drive Plus Motor, Extender STRYKER CORPORATION DEVAL PATEL
K152632 09/15/2015 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory STRYKER CORPORATION SORAYA KING
K152532 09/03/2015 AERO -C Cervical Cage System STRYKER SPINE SORAYA KING
K152771 09/25/2015 SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long SUMITOMO BAKELITE CO., LTD. SHIRO AGEHAMA
K152803 09/28/2015 SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE SUNG SHIM MEDICARE CO., LTD. KIM YOUNG KWAN
K152692 09/21/2015 Powder Free Vinyl Patient Examination Gloves (Green) Supermax Plastic Products Co., Ltd Wu Zhigang
K152648 09/16/2015 Ennova Self-adhesive Electrode Suzhou Ennova Electronics Technology Co.,Ltd N/A N/A
K152786 09/25/2015 A Plus Internal Fixture System T-PLUS IMPLANT TECH. CO., LTD. DANA CHENG
K152787 09/25/2015 ST Internal Fixture System T-PLUS IMPLANT TECH. CO., LTD. DANA CHENG
K152680 09/18/2015 TD-1035 Thermometer TAIDOC TECHNOLOGY CORPORATION C.W CHEN
K152535 09/04/2015 Z5 Slit lamp microscope, Z2 Slit lamp microscope TAKAGI SEIKO CO., LTD. Nagaike Yoshio
K152497 09/01/2015 PW Guidewires TATARA VASCULAR, LLC. KELLY EMERTON
K152869 09/30/2015 LipiView II Ocular Surface Interferometer TEARSCIENCE, INC. CHRISTY COLEMAN
K152835 09/29/2015 URITEK TC-201 URINE CHEMISTRY TEST SYSTEM TECO DIAGNOSTICS, INC. YUNYUAN VIVIAN WANG
K152525 09/03/2015 TR BAND Radial Compression Device TERUMO MEDICAL CORPORATION LIANG LU
K152521 09/03/2015 Seal Rite Non-Rebreathing Valve The Lifeguard Store, Inc. Amy Hilten
K152774 09/25/2015 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K152534 09/04/2015 Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose M TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CHAE CHUNG LYUEL
K152876 09/30/2015 LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM TNI Manufacturing, Inc. DANIEL SABLYAK
K152671 09/18/2015 Pulse Aloe-ahh TOASTER LABS, INC AMY C. BUCKALTER
K152628 09/15/2015 Pulse H20h! TOASTER LABS, INC AMY C. BUCKALTER
K152646 09/16/2015 SYLK PERSONAL LUBRICANT TORO MANAGEMENT LLC DBA SYLK MARIESSA MAHFOUZ
K152697 09/21/2015 INFX-8000C, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION JANINE REYES
K152696 09/21/2015 INFX-8000V, V6.20 Toshiba Medical Systems Corporation Paul Biggins
K152785 09/25/2015 XIDF-AWS801, Angio Workstation, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K152778 09/25/2015 TRACOE Cuff Pressure Monitor TRACOE MEDICAL GMBH STEPHAN KOHLER
K152865 09/30/2015 TRACOE smart Cuff Manager TRACOE MEDICAL GMBH STEPHAN KOHLER
K152559 09/09/2015 TruAbutment DS TRUABUTMENT BRANDON KIM
K152678 09/18/2015 TYRX Neuro Antibacterial Envelope TYRX, INC. REGINA NOVAK
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K152523 09/03/2015 JBAIDS Influenza A & B Detection Kit U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY ROBERT E MILLER
K152530 09/03/2015 UCP Stem UNITED ORTHOPEDIC CORPORATION KAREN HO
K152761 09/24/2015 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) VARIAN MEDICAL SYSTEMS, INC. MARCIA PAGE
K152789 09/25/2015 FLEX SCORING CATHETER VENTUREMED GROUP TIFFINI DIAGE
K152790 09/25/2015 Venus Versa System VENUS CONCEPT LTD. TAL BRESLER-STRAMER
K152518 09/03/2015 Vonflex S Putty VERICOM CO., LTD MYUNG-HWAN OH
K152615 09/14/2015 Vonflex S VERICOM CO., LTD. Myung-Hwan Oh
K152822 09/28/2015 VidiStar HeartView VIDISTAR, LLC CRAIG WALKER
K152894 09/30/2015 VIVIX-S 1717N Vieworks Co., Ltd Yoonjae Im
K152855 09/29/2015 VIVIX-S 1012N VIEWORKS CO., LTD. YOONJAE IM
K152611 09/14/2015 V20 system VIORA LTD. OMRI KESLER
K152734 09/22/2015 Kerrison Rongeurs VITALITEC MEDIZINTECHNIK GMBH LYNETTE HOWARD
K152582 09/10/2015 CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box VOLCANO CORPORATION NATHAN DA SILVA
K152829 09/29/2015 Visions PV.014P RX Digital IVUS Catheter Volcano Corporation Mary Stanners
K152551 09/08/2015 First Sign« Drug of Abuse Buprenorphine Cup Test, First Sign« Drug of Abuse Buprenorphine Dip Card Test, First Sign« Drug of Abuse Butalbital Cup Test, First Sign« Drug of Abuse Butalbital Dip Card Test, First Sign« Drug of Abuse Morphine Cup Test, First W.H.P.M., INC. JOHN WAN
K152609 09/14/2015 GORE SYNECOR Biomaterial W.L GORE & ASSOCIATES, INC. BARBARA L. SMITH
K152851 09/29/2015 BrainPort V100 WICAB, INC. ROBERT BECKMAN
K152782 09/25/2015 SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT WILLIAM A. COOK AUSTRALIA PTY LTD GORDANA POZVEK
K152717 09/21/2015 Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit WILLIAM A. COOK AUSTRALIA PTY, LTD. Gordana Pozvek
K152682 09/18/2015 Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit WILLIAN A. COOK AUSTRALIA PTY LTD GORDANA POZVEK
K152719 09/21/2015 Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves XINFU MEDICAL PRODUCTS CO., LTD. XIE WENXING
K152720 09/21/2015 Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color XINGDA MEDICAL PRODUCTS CO., LTD. ZHANG LIXIA
K152514 09/02/2015 Clickfine AutoProtect Pen Needle YPSOMED AG STEPHAN AFFOLTER
K152712 09/21/2015 Nitrile Powder Free Patient Examination Gloves, Blue Color Zhonghong Pulin Medical Products Co., Ltd. LI Jinge
K152755 09/24/2015 FastFrame External Fixation System-Ankle Spanning Zimmer, Inc. Dorothy Snyder
K152494 09/01/2015 Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments ZIMMER, INC. MARK D WARNER
K152841 09/29/2015 Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws ZIMMER, INC. DOROTHY SNYDER


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